Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Vitalograph, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
242 daysmedian FDA review time
506 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K000599 | VITALOGRAPH BASE STATION | Vitalograph, Inc. | 2000-09-08 | 199 | 0 |
| K991412 | VITALOGRAPH MICRO | Vitalograph, Inc. | 2000-02-04 | 287 | 0 |
| K943678 | ELECTRONIC FLOW METER | Vitalograph, Inc. | 1995-12-14 | 506 | 0 |
| K946075 | VITALOGRAPH MODEL 2120 | Vitalograph, Inc. | 1995-08-04 | 242 | 0 |
| K942779 | DISPOSABLE BACTERIOLOGICAL FILTER | Vitalograph, Inc. | 1994-07-13 | 30 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda